COVERED USES:

Prolastin® is indicated for congential Alpha1-antitrypsin (AAT) Deficiency.

Zemaira® is indicated for chronic augmentation and maintenance therapy in individuals with alpha1-proteinase inhibitior (A1-PI) deficiency and clinical evidence of emphysema.

Requests for a non-FDA approved ("off-label") indication requires the proposed indication be listed in either the American Hospital Formulary System (AHFS), USP-DI, or Drugdex and is considered subject to evaluation of the prescriber's medical rationale, formulary alternatives, the available published evidence-based research and whether the proposed use is determined to be experimental/investigational.

AGE RESTRICTIONS:

NA

PRESCRIBER RESTRICTIONS:

NA

REQUIRED MEDICAL INFORMATION:

For initiation of treatment, a prior authorization form and relevant chart notes documenting medical rationale are required and for continuation of therapy, ongoing documentation of successful response to the medication may be necessary.

CRITERIA:

Must meet all of the following:

• Member is non-smoker, AND
• Member has congenital deficiency (PiZZ, PiZ(null), or Pi(null, null) homozygous phenotypes) of AAT with serum concentrations less than 80mg/dl, less than 11 μM/L, or less than 0.8g/L (35% of normal), AND
• Member has progressive panacinar emphysema with a documented decline in FEV1

EXCLUSION CRITERIA:

NA

COVERAGE DURATION:

Initial authorization will be for up to six months. Reauthorization will be for up to one year.